US5462753A - Treatment of symptomatic benign prostatic hyperplasia - Google Patents
Treatment of symptomatic benign prostatic hyperplasia Download PDFInfo
- Publication number
- US5462753A US5462753A US08/056,130 US5613093A US5462753A US 5462753 A US5462753 A US 5462753A US 5613093 A US5613093 A US 5613093A US 5462753 A US5462753 A US 5462753A
- Authority
- US
- United States
- Prior art keywords
- potassium iodide
- treatment
- benign prostatic
- prostatic hyperplasia
- patients
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 206010004446 Benign prostatic hyperplasia Diseases 0.000 title claims abstract description 17
- 208000004403 Prostatic Hyperplasia Diseases 0.000 title claims abstract description 17
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 claims abstract description 63
- 238000000034 method Methods 0.000 claims description 3
- 229920006395 saturated elastomer Polymers 0.000 abstract description 2
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 208000024891 symptom Diseases 0.000 description 23
- 230000006872 improvement Effects 0.000 description 12
- 210000002307 prostate Anatomy 0.000 description 6
- 229940073402 potassium iodide oral solution Drugs 0.000 description 4
- 239000003814 drug Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002271 resection Methods 0.000 description 3
- 206010036976 Prostatism Diseases 0.000 description 2
- 208000025371 Taste disease Diseases 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- DBEPLOCGEIEOCV-WSBQPABSSA-N finasteride Chemical compound N([C@@H]1CC2)C(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H](C(=O)NC(C)(C)C)[C@@]2(C)CC1 DBEPLOCGEIEOCV-WSBQPABSSA-N 0.000 description 2
- 229960004039 finasteride Drugs 0.000 description 2
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 235000019656 metallic taste Nutrition 0.000 description 2
- 235000013336 milk Nutrition 0.000 description 2
- 239000008267 milk Substances 0.000 description 2
- 210000004080 milk Anatomy 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 229940113178 5 Alpha reductase inhibitor Drugs 0.000 description 1
- 239000002677 5-alpha reductase inhibitor Substances 0.000 description 1
- 206010071445 Bladder outlet obstruction Diseases 0.000 description 1
- 241000282472 Canis lupus familiaris Species 0.000 description 1
- 206010053155 Epigastric discomfort Diseases 0.000 description 1
- 208000010201 Exanthema Diseases 0.000 description 1
- 206010020843 Hyperthermia Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 206010062575 Muscle contracture Diseases 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 208000003800 Urinary Bladder Neck Obstruction Diseases 0.000 description 1
- 239000003098 androgen Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 208000006111 contracture Diseases 0.000 description 1
- 238000002574 cystoscopy Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 201000005884 exanthem Diseases 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000036031 hyperthermia Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000012148 non-surgical treatment Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 206010037844 rash Diseases 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 239000012047 saturated solution Substances 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 238000011477 surgical intervention Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 235000019640 taste Nutrition 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000001685 thyroid gland Anatomy 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/18—Iodine; Compounds thereof
Definitions
- Benign Prostatic Hyperplasia is common in adult males. Mankind is not unique in this regard and other animals with a compact or solid prostate, such as dogs, suffer comparably. BPH is particularly common in men over age 50. Patients with symptoms traditionally have been treated with transurethral resection of the prostate (TURP), a surgical technique that effectively reduces bladder outlet obstruction. TURP works best for those who need it most and it works poorest for those who need it least.
- TURP transurethral resection of the prostate
- finasteride alpha 1 blockers and/or 5 alpha-reductase inhibitor
- the maximum effects of finasteride on reducing prostatic volume occurs after three months of oral therapy. Most patients experience improvements in their symptoms and flow rates. However, serum DHT levels return to baseline within two weeks following discontinuation of the treatment. Most patients have to be on this for a long term to maintain the benefits. Moreover, it is fairly expensive medication at present. Similarly, beneficial effects of alpha 1 selective blockers take approximately two months to peak and have to be maintained on a long term basis for continued benefits in their symptomatology with BPH.
- the present invention is based on the discovery that potassium iodide can be used successfully for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) by administering an effective course of potassium iodide administered orally.
- BPH Benign Prostatic Hyperplasia
- the pharmaceutical preparation comprising potassium iodide in accordance with the present invention can be administered in a daily dose which averages about 50 to about 1000 milligrams of potassium iodide, preferably about 300 to about 600 milligrams of potassium iodide per daily dose.
- the potassium iodide is taken orally, in liquid drink, twice daily for five to ten days, preferably ten days.
- the potassium iodide may be taken every other day at twice the aforesaid daily dose.
- the potassium iodide may be administered carried in gelatin capsules or the like, or in suspension or solution in a palatable carrier that masks the taste.
- Potassium iodide oral solution is available from Upsher-Smith Laboratories, Inc., Minneapolis, Minn. under the trademark SSKITM. According to the manufacturer, SSKITM potassium iodide oral solution is a saturated solution of potassium iodide containing one gram of potassium iodide per milliliter. The potassium iodide oral solution should be diluted, for example, and taken with a glass of juice or milk.
- Table I shows their diagnosis and AUA symptom scores pre and post treatment.
- potassium iodide improvements symptoms in BPH is not understood at the present time.
- Potassium iodide is known to reduce vascularity in thyroid glands; however, whether or not it has any effect on vascular supply of prostate is not known.
- Potassium iodide was found to reduce AUA symptom scores in patients with symptomatic BPH.
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
Use of potassium iodide, administered orally, in an average daily dosage of 0.10 to 0.40 milligrams for the treatment of symptomatic Benign Prostatic Hyperplasia. The potassium iodide preferably is used in the form of a saturated aqueous solution of potassium iodide.
Description
Benign Prostatic Hyperplasia (BPH) is common in adult males. Mankind is not unique in this regard and other animals with a compact or solid prostate, such as dogs, suffer comparably. BPH is particularly common in men over age 50. Patients with symptoms traditionally have been treated with transurethral resection of the prostate (TURP), a surgical technique that effectively reduces bladder outlet obstruction. TURP works best for those who need it most and it works poorest for those who need it least. Other modalities for the treatment of patients with moderate or severe symptoms of BPH and/or those who are not suitable or do not elect to have a surgery also have been proposed, and data is being evaluated to determine the efficacy of treating symptomatic BPH with modalities such as a balloon dilatation, prostate hyperthermia, laser coagulation and prostatic stents. Recently, Doll et al reported in J. Urol., 147, 1566-1573, 1992, that 96% of severely symptomatic men experience improvement after transurethral resection of prostate, while only 18% of mildly symptomatic men improve.
Recently, non-surgical treatment of BPH has been suggested as an alternative, including androgen suppression using alpha 1 blockers and/or 5 alpha-reductase inhibitor (finasteride). The maximum effects of finasteride on reducing prostatic volume occurs after three months of oral therapy. Most patients experience improvements in their symptoms and flow rates. However, serum DHT levels return to baseline within two weeks following discontinuation of the treatment. Most patients have to be on this for a long term to maintain the benefits. Moreover, it is fairly expensive medication at present. Similarly, beneficial effects of alpha 1 selective blockers take approximately two months to peak and have to be maintained on a long term basis for continued benefits in their symptomatology with BPH.
The present invention is based on the discovery that potassium iodide can be used successfully for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) by administering an effective course of potassium iodide administered orally.
The pharmaceutical preparation comprising potassium iodide in accordance with the present invention can be administered in a daily dose which averages about 50 to about 1000 milligrams of potassium iodide, preferably about 300 to about 600 milligrams of potassium iodide per daily dose. Preferably the potassium iodide is taken orally, in liquid drink, twice daily for five to ten days, preferably ten days. Alternatively, the potassium iodide may be taken every other day at twice the aforesaid daily dose. Alternatively, the potassium iodide may be administered carried in gelatin capsules or the like, or in suspension or solution in a palatable carrier that masks the taste.
Potassium iodide oral solution is available from Upsher-Smith Laboratories, Inc., Minneapolis, Minn. under the trademark SSKI™. According to the manufacturer, SSKI™ potassium iodide oral solution is a saturated solution of potassium iodide containing one gram of potassium iodide per milliliter. The potassium iodide oral solution should be diluted, for example, and taken with a glass of juice or milk.
Administration of potassium iodide in accordance with the present invention has been observed to have a remarkable effect of improvements in uroflow and relief from symptoms of BPH.
The methods of the present invention will now be described by way of example, with reference to particular patients treated during trials of the invention.
Six patients were evaluated in a preliminary evaluation study. They all had a AUA symptom score recorded before and after the treatment with potassium iodide. A uroflow was obtained in all patients before and after the treatment. Two of the six patients had previous TURPs and had continued to experience moderate to severe prostatism symptoms. Results were evaluated based on improvements in AUA symptom scores, quality of life questions and improvements in their uroflow results.
Of the six patients three had BPH and two had transurethral resection of prostate in the past and still had significant prostatism as determined by AUA symptom scores. Table I shows their diagnosis and AUA symptom scores pre and post treatment.
Five of the six patients received the medication (10 drops-0.3 ml. of potassium iodide saturated solution-300 milligrams of potassium iodide-twice daily, taken orally with juice or milk) for ten days. One patient discontinued treatment on the fourth day because he developed gastric irritation, a severe metallic taste and a rash over his body. However, even he did notice a significant reduction in his symptoms (AUA score dropped from 11 to 4). One other patient reported a metallic taste for two to three days after stopping the medicine, but this reportedly disappeared spontaneously in 2-3 days.
Improvements in symptom scores of more than ten points occurred in all patients except one patient on whom cystoscopy done later revealed a diagnosis of contracture of bladder neck. His AUA symptom scores were 20 and 16 respectively before and after treatment. One other patient whose AUA symptom scored dropped to 18 from 28 and also noted improvement in flow still was not happy with his state of life and opted to have a TURP performed.
A six month follow-up is available in one patient. He developed recurrence of symptoms after three months. He took another ten day course and has been fine since then. In most cases an improvement was obvious by third or fourth day and peaked between the seventh and tenth day.
The four patients who noticed marked improvement in their symptoms were all considering a TURP for their symptomatic BPH. They were happy with the results. One patient opted for a TURP because he still was having moderate symptoms (AUA symptom score dropped to 18 from 28) and another is considering surgical intervention because he did not have a significant relief symptoms (AUA score dropped to 16 down from 20).
The improvements in symptoms in this study occurred within seven to ten days of treatment with potassium iodide oral solution. The improvements were quite significant as noted in Table I.
The mechanism whereby potassium iodide improvements symptoms in BPH is not understood at the present time. Potassium iodide is known to reduce vascularity in thyroid glands; however, whether or not it has any effect on vascular supply of prostate is not known.
TABLE 1
______________________________________
SYMPTOM SYMPTOM
CASE SCORE SCORE %
# PRE-Rx POST-Rx INCREASE
______________________________________
1 17 2 88
2 29 8 72
3 19 4 79
4 20 16 25
5 11 5 64
6 28 18 86
______________________________________
Potassium iodide was found to reduce AUA symptom scores in patients with symptomatic BPH.
While the invention has been described in connection with the preferred embodiment, various modifications may be made without departing from the spirit and scope thereof. It is intended that all such modifications which fall within the scope and spirit of the appended claims be embraced thereby.
Claims (2)
1. A method of treating symptomatic benign prostatic hyperplasia in a human male which comprises administering orally to the male an average daily dosage of 50 to 1000 milligrams of potassium iodide for a period of from five to ten days.
2. A method according to claim 1, wherein said potassium iodide is administered in an average daily dosage of 300 to 600 milligrams for a period of ten days.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/056,130 US5462753A (en) | 1993-04-30 | 1993-04-30 | Treatment of symptomatic benign prostatic hyperplasia |
| PCT/US1994/005123 WO1994025040A1 (en) | 1993-04-30 | 1994-05-02 | Use of potassium iodide for the treatment of symptomatic benign hyperplasia |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/056,130 US5462753A (en) | 1993-04-30 | 1993-04-30 | Treatment of symptomatic benign prostatic hyperplasia |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| US5462753A true US5462753A (en) | 1995-10-31 |
Family
ID=22002361
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US08/056,130 Expired - Fee Related US5462753A (en) | 1993-04-30 | 1993-04-30 | Treatment of symptomatic benign prostatic hyperplasia |
Country Status (2)
| Country | Link |
|---|---|
| US (1) | US5462753A (en) |
| WO (1) | WO1994025040A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7521479B2 (en) * | 2001-04-16 | 2009-04-21 | Panacea Pharmaceuticals, Inc. | Methods of treating prion disease in mammals |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX340005B (en) * | 2010-04-23 | 2016-05-18 | Univ Nac Autónoma De México | Molecular iodine composition for human use for the prevention and treatment of prostatic pathologies. |
| MX348541B (en) * | 2012-11-14 | 2017-06-01 | Univ Nacional Autónoma De México | Combination of molecular iodine and anthracyclines for human use for the prevention and treatment of iodine-capturing chemically-resistant cancers. |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4946688A (en) * | 1988-07-05 | 1990-08-07 | Fahim Mostafa S | Intraprostatic injection of zinc ions for treatment of inflammatory conditions and benign and malignant tumors of the prostate |
| US5102912A (en) * | 1990-10-24 | 1992-04-07 | Kanoldt Arzneimittel Gmbh | Hydroxyoctadecadienic acid for the treatment of estrogen-dependent disease |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2615641A1 (en) * | 1976-04-08 | 1977-10-20 | Josef Dipl Chem Dr Rer N Klosa | Pleasant tasting potassium iodide prepn. - by adding Aerosil (RTM) and opt. essential oils and mono- or di-saccharides |
-
1993
- 1993-04-30 US US08/056,130 patent/US5462753A/en not_active Expired - Fee Related
-
1994
- 1994-05-02 WO PCT/US1994/005123 patent/WO1994025040A1/en not_active Ceased
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4946688A (en) * | 1988-07-05 | 1990-08-07 | Fahim Mostafa S | Intraprostatic injection of zinc ions for treatment of inflammatory conditions and benign and malignant tumors of the prostate |
| US5102912A (en) * | 1990-10-24 | 1992-04-07 | Kanoldt Arzneimittel Gmbh | Hydroxyoctadecadienic acid for the treatment of estrogen-dependent disease |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7521479B2 (en) * | 2001-04-16 | 2009-04-21 | Panacea Pharmaceuticals, Inc. | Methods of treating prion disease in mammals |
Also Published As
| Publication number | Publication date |
|---|---|
| WO1994025040A1 (en) | 1994-11-10 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| REMI | Maintenance fee reminder mailed | ||
| LAPS | Lapse for failure to pay maintenance fees | ||
| FP | Lapsed due to failure to pay maintenance fee |
Effective date: 19991031 |
|
| STCH | Information on status: patent discontinuation |
Free format text: PATENT EXPIRED DUE TO NONPAYMENT OF MAINTENANCE FEES UNDER 37 CFR 1.362 |